Comparison of Interscalene Catheter to Single Injection Interscalene Blocks for Total Shoulder Arthroplasties

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Melinda Seering
Study ID
NCT05868330
Phase
PHASE4
Status
Recruiting
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Conditions

  • Anesthesia
  • Nerve Block
  • Post Operative Pain
  • Shoulder Osteoarthritis

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • Interscalene Catheter — PROCEDURE
    Pre-operatively the patient will have a interscalene catheter placed by a regional skilled anesthesiologist. The initial block will be with 20 cc of 0.5% Bupivacaine and maintained on an infusion post-operatively at 8cc/hr of 0.2% ropivacaine as is our intuitions protocol
  • Exparel Single Shot Interscalene Block — PROCEDURE
    Pre-operatively the patient will have a interscalene single shot block with 133 mg Liposomal Bupivacaine and 10 ccs 0.5% Bupivacaine placed by a regional skilled anesthesiologist.

Study Details

Comparison of post-operative pain after total shoulder surgery. The Principle Investigator will be comparing Exparel single shot block to Interscalene catheter

Key Dates

Start date
Aug 19, 2024
Status verified
Nov 2025
Primary completion
Oct 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Interscalene Catheter
    One of the current standard of care for shoulder replacement surgery at our institution is to receive an interscalene catheter for pre-operatively
  • Active Comparator: Exparel Single Shot Interscalene Block
    One of the current standard of care for shoulder replacement surgery at our institution is to receive a pre-operative single shot interscalene block with Exparel

Primary Outcome Measure

Pain Score Assessed by functional pain score at POD 1 [ Time Frame: The primary outcome will occur at 1 day after surgery date ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa Hospital and ClinicsIowa CityIowa52242
Melinda Seering, M.D.
[email protected]
319-384-8075

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By research site
University of Iowa Hospital and Clinics· Iowa City, IA

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